Harmonising Packaging and Labelling Rules for Medical Devices: A Step Towards Regulatory Clarity

The recent amendment to the Legal Metrology (Packaged Commodities) Rules, 2011 — through the Legal Metrology (Packaged Commodities) Amendment Rules, 2025 (Notification No. G.S.R. 778(E), dated 24 October 2025) — marks a significant regulatory development for the medical device sector. By aligning the packaging and labelling requirements for medical devices with the Medical Devices Rules, 2017, the amendment effectively removes a long-standing overlap between the Legal Metrology framework and the medical device regulatory regime.

Rationale for Harmonisation:

This harmonisation is both logical and timely. Medical devices are not pharmaceutical formulations; their risk profiles, manufacturing standards, and usage contexts are distinct. Applying drug-style labelling requirements to medical devices often led to unnecessary complexity and interpretational confusion. The new amendment resolves this by providing a clear, uniform framework tailored to the nature of medical devices, thereby improving regulatory predictability and industry compliance.

Benefits for Stakeholders:

For manufacturers and importers, this shift offers several advantages. It reduces duplicative labelling obligations, simplifies packaging artwork approvals, and ensures consistency in how critical product information, such as device category, manufacturing details, and usage indications, is communicated.

For consumers and healthcare providers, it improves transparency and comparability of device information. Most importantly, it signals the government’s recognition that medical devices constitute a specialised sector deserving of a distinct and rational compliance environment.

Implementation and Compliance Concerns:

As the amendment comes into force on the date of its publication, i.e., 24 October 2025, some clarity may still be needed on the time that may be available to carry out the relabelling and achieve full compliance with the amended rules. A short transition window, even a few months, would go a long way in ensuring that the spirit of reform is implemented efficiently without disruption to ongoing manufacturing and supply chains.

Conclusion:

The amendment is undoubtedly a progressive step. The only missing piece is a practical implementation timeline to match the policy intent — ensuring that the industry can transition smoothly while maintaining regulatory efficiency and market continuity.